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APTT CoaguDx Test Strip
EUDAMEDClass IVD General (EU MDR)
Ref W-CL1-APTT-SC-96Model 96 Strips / Kit (Note: One-step method)
Identity
- Trade Name
- APTT CoaguDx Test Strip EUDAMED
- Device Name
- APTT CoaguDx Test Strip EUDAMED
- Model / Reference
- 96 Strips / Kit (Note: One-step method) EUDAMEDW-CL1-APTT-SC-96 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978896413737 EUDAMED
- Basic UDI-DI
- B-06978896413737 EUDAMED
- EMDN Code
- W0103020102 ACTIVATED PARTIAL THROMBOPLASTIN TIME EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
APTT CoaguDx Test Strip by Wuhan Easydiagnosis Biomedicine Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06978896413737 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wuhan Easydiagnosis Biomedicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000019908
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 7ddda23e-398d-4e29-b177-6dd7bd1f0c9d 61 fields · synced Oct 7, 2026